MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number 7RSL021

Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)

Patient Problems Erythema (1840); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 11/22/2017

Event Type  malfunction  

Event Description

This unsolicited case from united states was received on 30-apr-2018 and 01-may-2018 from the patient, both the information was processed together with clock start date 30-apr-2018.This case involves a patient (demographics: not provided) who received treatment with synvisc one and after few days the patient had trouble walking, knee pain, knee redness and knee swelling (after unknown latency).Also, device malfunction was identified for the reported lot number.No medical history, past drugs, concurrent condition was provided.Concomitant medications included simvastatin, amlodipine, alprazolam, metoprolol tartrate (metoprolol), fish oil, low dose acetylsalicylic acid (aspirin).On an unknown date in (b)(6) 2017, the patient initiated treatment with intra-articular, injection (dose: not provided; batch/lot number: 7rsl021) for pain relief for knee.It was reported that the patient had an injection of synvisc one which was from a contaminated lot, lot #7rsl021.On (b)(6) 2017 (after unknown latency), the patient experienced pain, swelling, redness, trouble walking, was later called by physician to be informed of the contamination.The patient had to go to the hospital for blood tests, apparently the blood tests were satisfactory.The blood tests were done a month later but had lesser levels of pain and swelling for 2 months.It was reported that the problem did not stop after the patient reduced the dose or stopped taking or using the product.Corrective treatment: not reported for all events outcome: recovering for device malfunction was identified for the reported lot number, knee pain, knee swelling; unknown for rest of the events.Seriousness criterion: medically significant for all events.A product technical complaint (ptc) was initiated and results were pending for the same.An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Pharmacovigilance comment: sanofi company comment dated 30-apr-2018: this case concerns a patient who suffered from pain, swelling of knee, knee redness and trouble walking after receiving synvisc one injection from the recalled lot.Temporal relationship can be established between the events and the suspect product based on the available information.Additionally, as the concerned lot number has been identified to have malfunction by the company, therefore, pharmacological plausibility of the events to the product cannot be excluded.

Event Description

Device malfunction [device malfunction] knee redness [localized erythema] trouble walking [difficulty in walking] knee pain [knee pain] knee swelling [knee swelling].Case narrative: this unsolicited case from united states was received on 30-apr-2018 and 01-may-2018 from the patient, both the information was processed together with clock start date (b)(6) 2018.This case involves a patient (demographics: not provided) who received treatment with synvisc one and after few days the patient had trouble walking, knee pain, knee redness and knee swelling (after unknown latency).Also, device malfunction was identified for the reported lot number.No medical history, past drugs, concurrent condition was provided.Concomitant medications included simvastatin, amlodipine, alprazolam, metoprolol tartrate (metoprolol), fish oil, low dose acetylsalicylic acid (aspirin).On an unknown date in (b)(6) 2017, the patient initiated treatment with intra-articular, injection (dose: not provided; batch/lot number: 7rsl021) for pain relief for knee.It was reported that the patient had an injection of synvisc one which was from a contaminated lot lot #7rsl021.On (b)(6) 2017 (after unknown latency), the patient experienced pain, swelling, redness, trouble walking, was later called by physician to be informed of the contamination.The patient had to go to the hospital for blood tests, apparently the blood tests were satisfactory.The blood tests were done a month later but had lesser levels of pain and swelling for 2 months.It was reported that the problem did not stop after the patient reduced the dose or stopped taking or using the product.Corrective treatment: not reported for all events.Outcome: recovering for device malfunction was identified for the reported lot number, knee pain, knee swelling; unknown for rest of the events a product technical complaint (ptc) was initiated on (b)(6) 2018 for synvisc one batch number: unknown global ptc number:(b)(4).An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events was under investigation.Once this investigation would be completed, corrective and preventive actions would be implemented.Seriousness criterion: medically significant for all events.Follow up information was received on 17-may-2018.Global ptc number was added.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• MDR Report Key: 7510668
• MDR Text Key: 108733512
• Report Number: 2246315-2018-00475
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETYLSALICYLIC ACID (ACETYLSALICYLIC ACID),UNKNOW; ALPRAZOLAM (ALPRAZOLAM),UNKNOWN; ALPRAZOLAM(CON.); AMLODIPINE (AMLODIPINE),UNKNOWN; AMLODIPINE(CON.); ASPIRIN(CON.); FISH OIL (FISH OIL),UNKNOWN; FISH OIL(CON.); METOPROLOL (METOPROLOL),UNKNOWN; METOPROLOL(CON.); SIMVASTATIN (SIMVASTATIN),UNKNOWN; SIMVASTATIN(CON.)
• Patient Outcome(s): Other